November 25, 2014
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Drug Factsheets

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Salofalk

(5-aminosalicylic acid (mesalamine, mesalazine))

DIN (Drug Identification Number)

02242146 SALOFALK 1000 MG SUPPOSITORIES
02112795 SALOFALK 2G/60G RECTAL SUSPENSION
02112809 SALOFALK 4G/60G RECTAL SUSPENSION
02112760 SALOFALK 500MG SUPPOSITORIES
02112787 SALOFALK 500MG ENTERIC-COATED TABLET

How does Salofalk work? What will it do for me?

5-aminosalicylic acid (5-ASA or mesalamine) belongs to the group of medications known as anti-inflammatories. It is used to treat mild to moderate ulcerative colitis and mild to moderate Crohn's disease. 5-ASA acts by reducing inflammation in the bowel.

Different brands of 5-ASA are designed to act on different places in the gastrointestinal tract (the digestion tube that runs from the mouth to the anus). Ulcerative colitis affects the colon and rectum only, while Crohn's disease affects the whole gastrointestinal tract. For this reason, some brands are used to treat only ulcerative colitis, while others can be used to treat both Crohn's disease and ulcerative colitis.

This medication may be available under multiple brand names and/or in several different forms. Any specific brand name of this medication may not be available in all of the forms or approved for all of the conditions discussed here. As well, some forms of this medication may not be used for all of the conditions discussed here.

Your doctor may have suggested this medication for conditions other than those listed in these drug information articles. If you have not discussed this with your doctor or are not sure why you are using this medication, speak to your doctor. Do not stop using this medication without consulting your doctor.

Do not give this medication to anyone else, even if they have the same symptoms as you do. It can be harmful for people to use this medication if their doctor has not prescribed it.

How should I use Salofalk?

Tablet: The recommended adult dose of this medication depends on the product selected. Swallow the tablets whole, ensuring that you do not break the outer coating. Take the tablets only as prescribed. Do not change the number or frequency of tablets taken without first consulting your doctor.

Suppository, rectal suspension, and enema: The usual dose for suppositories, rectal suspension, and enema is 1 g to 4 g daily divided into 1 or 2 doses, or as prescribed by the doctor.

For the proper administration of these dosage forms, check with your pharmacist.

Many things can affect the dose of a medication that a person needs, such as body weight, other medical conditions, and other medications. If your doctor has recommended a dose different from the ones listed here, do not change the way that you are using the medication without consulting your doctor.

It is important to use this medication exactly as prescribed by your doctor. If you miss a dose, administer it as soon as possible and continue with your regular schedule. If it is almost time for your next dose, skip the missed dose and continue with your regular dosing schedule. Do not administer a double dose to make up for a missed one. If you are not sure what to do after missing a dose, contact your doctor or pharmacist for advice.

Store all forms of this medication at room temperature, protect them from light and moisture, and keep them out of the reach of children.

Do not dispose of medications in wastewater (e.g. down the sink or in the toilet) or in household garbage. Ask your pharmacist how to dispose of medications that are no longer needed or have expired.





What form(s) does Salofalk come in?

Rectal Suspension

2 g/60 g
Each unit of use rectal retention enema contains 5-ASA 2 g/60 g. Nonmedicinal ingredients: carbomer, edetate disodium, potassium acetate, potassium metabisulfite, purified water, sodium benzoate, and xanthan gum.

4 g/60 g
Each unit of use rectal retention enema contains 5-ASA 4 g/60 g. Nonmedicinal ingredients: carbomer, edetate disodium, potassium acetate, potassium metabisulfite, purified water, sodium benzoate, and xanthan gum.

Suppositories

500 mg
Each smooth, light tan to grey, bullet-shaped suppository contains 5-ASA 500 mg. Nonmedicinal ingredient: Witepsol H-15 (suppository wax base).

1000 mg
Each smooth, light tan to grey, bullet-shaped suppository contains 5-ASA 1,000 mg. Nonmedicinal ingredient: Witepsol H-15 (suppository wax base).

Tablets

Each ochre-coloured, oblong, biconvex tablet contains mesalamine (5-ASA) 500 mg. Nonmedicinal ingredients: carnauba wax, colloidal silicon dioxide, glycine, hydroxypropyl methylcellulose, iron oxide, magnesium stearate, methacrylic acid copolymer, microcrystalline cellulose, polydimethyl siloxane, polysorbate, povidone, sodium carbonate, sodium hydroxide, talc, titanium dioxide, and triethyl citrate.

Who should NOT take Salofalk?

Do not use this medication if you:

  • are allergic to 5-aminosalicylic acid or any ingredients of the medication
  • are allergic to other salicylates (e.g., ASA)
  • are not able to swallow tablets whole
  • have a gastric (stomach) or duodenal (intestinal) ulcer
  • have a urinary tract obstruction

Do not give this medication to children under 2 years of age.

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